One of the best-documented critiques of cloning human embryos has appeared in the latest issue of the Journal of Medical Ethics. In an article entitled "Why the apparent haste to clone humans?" Dr Neville Cobbe, of the Wellcome Trust Centre for Cell Biology at the University of Edinburgh, asks why scientists are rushing ahead with human cloning before validating this approach with animal studies.
This point -- often overlooked in debates -- is a crucial issue. In a stinging challenge to supporters of embryo cloning, Cobbe points out that two inconclusive papers are the main props for the contention that no more animal research is needed. One reported an experiment which succeeded only with the help of adult stem cells and the other dealt with the brain, whose immunology is quite different from the rest of the body.
In recent months, especially after the Korean stem cell debacle, calls for therapeutic cloning have become more muted as the extent of the technical obstacles has become clearer. However cloning embryos for research is still strongly supported by most stem cell scientists. Cobbe points out, however, that even this approach is flawed because of significant variations in gene expression between clones. Ian Wilmut, Britain's premier spokesman for cloning, admits that cloned offspring are more even variable than siblings. This implies that it might prove impossible to interpret studies which aim at identifying the subtle differences in the way drugs work on a genotype.
Cobbe acknowledges that "something resembling part of the promise of therapeutic cloning may become feasible some time in the distant future". But he argues that much more basic science is needed. In the meantime, scientists should concentrate on mouse models. "If we now allow such human experimentation without prior and thorough validation from humane work in other species, do we really know where we are going?"
Cobbe also stresses the potential for exploitation of humans. The first beneficiaries of any therapies would be the wealthy, as the cost of cloning will be very high. Obtaining eggs will be costly, risky and could exploit poorer women in the developing world. Cobbe concludes that "it would appear that a host of vested interests may have played a significant role in encouraging potentially profound misrepresentation of both the science surrounding cloning and its foreseeable clinical implications." ~ Journal of Medical Ethics, May (subscription only)
"FUTILE CARE" LAW UNDER FIRE IN TEXAS
A "futile care" law in Texas has come under fire from anti- euthanasia activists after doctors allegedly gave up on a 54-year- old woman who was being kept alive with the help of a respirator and a dialysis machine.
On April 19, an ethics committee at St Luke's Episcopal Hospital gave the family of Andrea Clark 10 days to find another facility or doctor to treat her. If nothing was done, under a 1999 law signed by George W. Bush, who was then governor, her life support would be removed because further treatment would be deemed medically futile.
Ms Clark, a widow with a 23-year-old son, was an early success in the first "blue baby" heart operations, but she has had poor health for most of her life. Her current crisis began in November and her condition deteriorated in January after open-heart surgery. In recent days, another doctor has taken on her case and she appears to have improved.
She has left no advanced directive, but her family says that she has expressed a clear desire to live. They were outraged at the hospital's move. Online forums and blogs galvanised public protest and the hospital was flooded with angry callers. "The real story is a law that allows physicians and ethics committees to make life-and-death decisions based on what they perceive a patient's quality of life to be," said Mrs Clark's lawyer. "It's unfortunate Texas has become ground-zero for this futile-care movement."
The Clark case is just one of several controversial applications of the futile-care law. "One problem with the law is that it gives all the bargaining power to the hospital and doctors," says bioethicist William Winslade, of the University of Texas Medical Branch at Galveston. "I think it would be better if an external mediator looked at cases. I'm sympathetic to hospitals on these issues, but I've talked to too many families who feel browbeaten and without recourse." ~ Houston Chronicle, Apr 28
STANFORD TRIALS "DIAL AN ETHICIST" SERVICE FOR SCIENTISTS
The growing awareness of bioethics has given rise to institutional review boards which oversee and regulate federally funded research in the US. But often scientists need on-the-spot ethical advice in the course of a project. To provide this, Stanford University bioethicists have devised a bench-side consultation service. According to David Magnus, they hope to integrate ethical thinking into a scientist's everyday life -- something that often seems to be missing. "A lot of scientists don't really see ethics as a part of their job," says his colleague Mildred Cho. Over the past six months, the service has helped seven different Stanford research groups.
Giving this kind of non-binding, voluntary advice can be hazardous, as Insoo Hyun, of Case Western Reserve University discovered too late. He worked with disgraced stem cell scientist Hwang Woo-suk to refine informed consent procedures for his experiments -- and later discovered that Hwang had blatantly ignored them. He was forced to withdraw a paper describing what he had done in the American Journal of Bioethics. "Being an ethical consultant doesn't put you in a position to prevent misconduct," he says.
Critics of the "dial-an-ethicist" approach complain that bioethicists are often too close to scientists. They merely provide an ethical gloss for projects, contends Vera Sharav of the Alliance for Human Research Protection. And a Nature editorial recalled the words of political scientist Langdon Winner to a Congressional science committee in 2003: "The professional field of bioethics has a great deal to say about many fascinating things, but people in this profession rarely say 'no'... Indeed, there is a tendency for career-conscious social scientists and humanists to become a little too cosy with researchers in science and engineering, telling them exactly what they want to hear." ~ Nature, Apr 27
BIG PHARMA PUTS SALES BEFORE SCIENCE, SAY CRITICS
Drug manufacturers are placing salesmanship before science, according to critics cited in Wired magazine. "The dominance of marketing over research has done real damage to company pipelines," says Jurgen Drews, a former research chief for the pharmaceutical giant Roche. Wired charges that the industry is spending billions on sometimes trivial remedies and copycat drugs, even though fewer drugs are being developed, patents on old drugs are expiring and critical areas of medicine are being ignored.
The drug industry is sailing in rough financial waters at the moment: the 10 largest companies have lost US$130 billion in combined market value over the last two years; there have been a number of scandals over drug safety and controversial sales practices; and 17 drugs have been recalled.
Although pharmaceutical companies deny that research has been compromised by a focus on sales, they spend twice as much on marketing and administration than on research. And a significant proportion of research budgets is spent on clinical trials of already approved drugs. Often trials are done mainly to establish that one drug is better than a rival's.
Marketing direct to consumers has become much more important for drug companies since 1997 when the US Food and Drug Administration allowed them to advertise their products on television without lengthy descriptions of side-effects. As a result, drugs designed for a narrow band of patients were requested by a much broader audience. "It creates demand where there's not even disease there," complains Dr Robert Centor, of the University of Alabama. ~ Wired, Apr 28
GERIATRIC MERCY KILLINGS
A 83-year-old Texas man dying of cancer who had nursed his partially paralysed wife for 13 years has been charged with her murder. Doctors say that James Roberson will probably die within months and his case may never come to trial. Police in Dallas speculated that either he did not want his wife Mary to go to a nursing home after his death or he did not want to leave her alone.
The killing has been widely described as an act of compassion. However, a Colorado State University expert on mercy killings, Silvia Sara Canetto, disagreed. "Whether it's compassionate for the other person [who is killed] is difficult to answer," she said. "I would say it's not." ~ AP, Apr 27; Dallas Morning News, Apr 26
In similar case in the UK, a 75-year-old man who killed his dementia-stricken wife with porridge laced with paracetamol tablets has been given a 12-month suspended sentence. Frank Burton was so distressed by the poor care that his wife was receiving in hospital that he took her home on New Year's Eve and killed her and tried to commit suicide himself. The couple had been married for 55 years. ~ Sheffield Today, Apr 26
EUTHANASIA RISES IN NETHERLANDS
The 2005 figures for legal euthanasia in the Netherlands show a slight increase on the previous year. The Regional Oversight Boards for Euthanasia says that doctors reported 1,933 cases, up from 1,886 in 2004 and 1,815 in 2003. Experts say that only about half of Dutch euthanasia cases are reported, notwithstanding government guidelines. In three cases, the doctors were referred for possible prosecution. Two of them had not consulted sufficiently with an independent doctor and one had been a personal friend of the person who died.
Dutch authorities still insist that doctors participate in euthanasia. This month a court sentenced a 49-year-old man, known as A de G, to 15 months in jail for helping a friend commit suicide with an overdose of heroin and methadone. The friend was suffering from an obsessive-compulsive neurosis. The panel of judges said that de G had not stuck to guidelines which require that a medical professional be involved. ~ Expatica, Apr 21
TRUDGING AFTER HWANG
Although the work of Korean stem cell scientist Hwang Woo-suk has been exposed as a fraud, at least seven groups around the world are attempting to create human embryonic stem cells. The scandal has not diverted them from their research goals, but it did make them rethink their strategies on how to achieve them. A variety of approaches are being taken in the key areas of obtaining human eggs and financial backing.
In the US, scientists at Harvard Medical School will rely on compassionate donors" to provide eggs. Harvard is funding their work, along with some private donors. In New York, a lab at the Memorial Sloan-Kettering Cancer Center is working with Rockefeller University and Weill Cornell Medical Center. In California, a team at the University of California San Francisco will be using eggs which failed to fertilise in IVF treatment.
In the UK, Ian Wilmut, the creator of the first cloned mammal, Dolly the sheep, is thinking of using rabbit eggs instead of human eggs to create hybrid stem cells. At the University of Newcastle upon Tyne, a team is trying to build on its success in creating cloned human embryos -- the only group to have published a paper documenting their work. And in Spain, a former member of the Newcastle team has set up shop in Valencia where he hopes to use fresh human eggs.
Finally, in China, the Shanghai Institutes for Biological Sciences, is seeking government approval for human cloning. "Hwang's work was fake, but someone has to do the real thing," says Guotong Xu, deputy director of the Institute of Health Sciences. In Korea, Seoul National University has confirmed earlier findings that Hwang never successfully cloned a human embryo. The apparent clone was actually the result of parthenogenesis, a form of reproduction in which the embryo develops from an unfertilised egg. ~ Science, Apr 28; Chosun Ilbo, May 1
OVERHAUL CLINICAL TRIALS, SAYS NIH
Procedures for clinical trials must be revised to protect the public and restore public faith in medicine, says the director of the US National Institutes of Health, Elias Zerhouni. He has released an eight-point plan to improve trials and reduce the prospect of ignoring adverse results.
A key recommendation is to give equal weight to safety and efficacy. The NIH feels that a focus on efficacy was one of the problems that ultimately led to the 2004 withdrawal of Merck's pain killer Vioxx. It has also called for researchers to treat prior observations with greater scepticism, pointing to flaws in studies of hormone replacement therapy, which appears to be associated with a higher risk of circulatory disease. Statistics can also mislead both practitioners and patients, says the NIH, particularly when drug efficacy is discussed in terms of relative risk without reference to the absolute risk. ~ BMJ, Apr 29
IN BRIEF: IVF for assassin; dignity in UK hospitals
IVF for Israeli assassin: The Israeli High Court of Justice has issued an injunction to prevent the killer of former prime minister Yitzhak Rabin from using IVF to have a child with his wife. Although the Israeli Prison Service approved the procedure for Yigal Amir, two members of the Knesset have demanded that the order be rescinded. ~ Haaretz, May 1
UK dignity: British doctors and other health care staff are being exhorted to treat older patients with dignity. "Dignity is everybody's business," says health minister Liam Byrne. "So we'll be asking watchdogs, nurses, doctors and newly appointed older people's champions to join together with one goal -- to make dignity in care a priority." The government says that every hospital will have a nurse in charge of enforcing elderly persons' dignity. ~ BMJ, Apr 29
